Contact information
Type
Scientific
Primary contact
Dr Lionel Carmant
ORCID ID
Contact details
Service de Neurologie
Hôpital Sainte-Justine
3175 Chemin de la Côte Ste-Catherine
Montréal
Quebec
H3T 1C5
Canada
+1 514 345 4931 (6106)
lionel.carmant@umontreal.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-53573
Study information
Scientific title
Acronym
Study hypothesis
To determine whether infants and children receiving the Infantile Spasms (IS) standard therapy as well as Flunarizine will have an improved developmental outcome as compared to that of children receiving the same treatment with a placebo.
Ethics approval
Ethics approval received from the Hôpital Sainte-Justine, Comité d'éthique de la recherche on the 15th July 2004.
Study design
Randomised double blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Infantile Spasms (IS)
Intervention
All infants and children will receive initial IS conventional therapy, consisting of Vigabatrin (VGB) administration (as well as vitamin B6), followed after a two week period by Adrenocorticotropic Hormone (ACTH - Synacthen) treatment, if no IS cessation or amelioration occurs. Moreover, if the infants or children's' IS still do not respond to the latter hormone, they may be treated with Topiramate.
Besides the standard IS treatment, Flunarizine or placebo will be administered from the onset of the study for a total of six months in order to determine its efficacy in preventing or ameliorating the mental deterioration associated with IS. After this time, all treatment will be ceased.
Following cessation of treatment, the neurological and neuro-psychological status of infants and children will still be followed for an additional one and one half year period to determine their long-term response to Flunarizine (and to placebo) and to assess their mental development.
Intervention type
Drug
Phase
Not Specified
Drug names
Flunarizine, vigabatrin, synacthen, topiramate
Primary outcome measures
Intelligence Quotient (IQ) scores are evaluated with Bayley scales at time 0 and 24 months.
Secondary outcome measures
1. Autistic behaviour
2. Longitudinal development and pattern of developmental progress in infants and children
3. Occurrence of IS
Overall trial start date
01/04/2002
Overall trial end date
31/03/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children aged 3 - 18 months, either sex, with new onset infantile spasms
2. Electroencephalogram (EEG) showing hypsarrhythmia or modified hypsarrhythmia
3. Children not receiving treatment for infantile spasms at the time of the initial visit, i.e. vigabatrin or synacthen
4. Parents or legal guardian agree to sign the consent form
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Age under 3 months or over 18 months at onset of spasms
2. Degenerative neurological disorder because their relentless course toward a poor outcome regardless of therapeutic interventions would limit the possibility of generalising our findings to all children with infantile spasms
3. Pre-existing medical condition where steroids would be contraindicated
4. Families unable to comply with follow-up visits or agree to informed consent
Recruitment start date
01/04/2002
Recruitment end date
31/03/2006
Locations
Countries of recruitment
Canada
Trial participating centre
Service de Neurologie
Montréal, Quebec
H3T 1C5
Canada
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-53573)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary